FDA Clears 28 Orthopedic and Spine Devices in February

The FDA issued 28 orthopedic- and spine-related 510(k) clearances in February, according to a report by the FDA.

Advertisement

1. Atlas Intervertebral Body Cage from Spinal Edge
2. Implantable Clip from Genicon
3. Evolve EPS Ortholoc from Wright Medical Technology
4. DePuy Fracture and Fusion Plating System from DePuy Orthopaedics  
5. Corin Metafix Femoral Stem from Corin U.S.A.
6. ESL Spinal System from EBI L.P.
7. Spine 360 Anterior Cervical Plate System from Spine 360
8. Omnispan Mensical Repair System/0 Degree, Model 228140 from DePuy Mitak
9. Rapidloc A2 Mensical Repair System/12 Degree, Model 228141 from DePuy Mitak
10. Firebird Spinal Fixation System, Firebird Side-Loading Body from Blackstone
11. Longevity IT Highly Crosslinked Polyethylene Elevated Liners from Zimmer
12. Uniplate Anterior Cervical Plate System from DePuy Spine
13. Active Knee Total Knee Replacement System from Anova Implant Solutions
14. Modification to Capsure PS System from Spine Wave
15. Skeltex ISV from Skeltex Technologies
16. Zimmer Patient-Specific Instruments System, Version 2.0 from Materialise
17. Zodiac Poliaxial Spinal Fixation System from Alphatec Spine
18. Edgelock from Orthohelix Surgical Designs
19. Pioneer Posterior Cervico-Thoracic System from Pioneer Surgical Technology
20. Oscar 3 from Orthosonics
21. Genesis Unicondylar UHMWPE Articular Inserts from Smith & Nephew
22. Pogo Screw Instrumentation Tray from FxDevices
23. Smith & Nephew Sureshot Distal Targeting System V2.0 from Smith & Nephew
24. Arthrosteer Ablator & Coagulator Models REF 1070 & 1080 from Orthodynamix
25. Mako Surgical Robotic Arm Interactive Orthopedic System-THA from Mako Surgical Corp.
26. Powerpump Arthroscopy System from Medical Vision
27. Binder Intervertebral Body Fusion Device from Binder Biomedical
28. Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020 from Carefusion

See the full list of FDA clearances.

Advertisement

Next Up in Spinal Tech

Advertisement

Comments are closed.